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Neffy Broadcast Ad False or Misleading: OPDP

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An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy nasal spray.

Public Citizen Sues Over Drug Price Deals

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Public Citizen asks a federal court to order the Trump administration to make public the terms of drug pricing deals it signed wit...

FDA Warns HIV Testing Companies on Collection Devices

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An Akin legal update says FDAs recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of una...

FDA Cites Sterile Compounding Lapses at Nubratori

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FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the ...

HHS OIG Outlines Safe Harbor for DTC Drug Sales

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HHS Office of Inspector General issues new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs direc...

FDA Denies Ozempic Petition Without Substantive Comment

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Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firms petition seeking restrictions ...

124 Novel Medical Devices Authorized in 2025: Report

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The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authoriz...

2 Regenxbio Gene Therapies Get Clinical Holds

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FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the i...

Drug Companies Using AI to Speed Submissions

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Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensiv...

FDA Enforcement Year in Review

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A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regula...